?Effect of probiotic on immune system and oxidative stress in intensive care unit patients

The effect of seven-strain probiotic supplementation on some of the Thelpers, ICAM, VCAM, prooxidant-antioxidant balance, oxidative stress and inflammatory biomarkers and nutritional status in patients with head trauma admitted to intensive care unit: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100209003320N18

Enrollment

Registered

2020-09-07

Start date

2020-09-20

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Trauma. Acute post-traumatic headache

Interventions

Intervention 1: Intervention group: Patients in this group will receive a probiotic supplement for 14 days. The supplement is: a capsule containing seven types of probiotics (produced by Zist takhmir

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age 60 to 18 years Low level of consciousness (GCS <8) Nutrition through the nasal - stomach tube Willingness to cooperate by obtaining the consent of first-degree relatives Patients receiving gavage Presence in the intensive care unit for at least 14 days Having an APACHE II score of 15–30

Exclusion criteria

Exclusion criteria: Pregnancy- Breastfeeding Parental nutrition (more than two days) Taking immunosuppressive medications Unstable hemodynamics Intestinal obstruction; intestinal ischemia; short bowel syndrome

Design outcomes

Primary

Measure	Time frame
Th-17, T-regulatory, Th10 cells. Timepoint: Beginning and end of the trial. Method of measurement: Flowcytometry.;Duration of hospitalization and rate of attenuation. Timepoint: Daily. Method of measurement: Observation and questionnaire.;Respiratory tract infection. Timepoint: Beginning and end of the trial. Method of measurement: Sputum Culture.;Serum levels of TGF-ß. Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Serum levels of IL-6. Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Serum levels of IL-1ß. Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Level of consciousness and severity of the disease. Timepoint: Daily. Method of measurement: GCS , APACHE and SOFA Questionnaire.;Weight. Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula.;Body mass index. Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula.	—

Measure

Time frame

Th-17, T-regulatory, Th10 cells. Timepoint: Beginning and end of the trial. Method of measurement: Flowcytometry.;Duration of hospitalization and rate of attenuation. Timepoint: Daily. Method of measurement: Observation and questionnaire.;Respiratory tract infection. Timepoint: Beginning and end of the trial. Method of measurement: Sputum Culture.;Serum levels of TGF-ß. Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Serum levels of IL-6. Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Serum levels of IL-1ß. Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Level of consciousness and severity of the disease. Timepoint: Daily. Method of measurement: GCS , APACHE and SOFA Questionnaire.;Weight. Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula.;Body mass index. Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula.

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Secondary

Measure	Time frame
Energy, macronutrients and antioxidant nutrients (vitamins A, E, C, selenium, zinc and copper) intake. Timepoint: Beginning and end of the trial. Method of measurement: Food record (gavage) - Nutritionist 4 software.;Intercellular adhesion molecule-1 (ICAM-1). Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Vascular cell adhesion molecule 1 (VCAM-1). Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Pro-oxidant-Antioxidant Balance (PAB). Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Total antioxidant capacity (TAC). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method.;Malondialdehyde (MDA). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method.;Nitric oxide (NO). Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;?Arylesterase (ARE) activity. Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method.	—

Measure

Time frame

Energy, macronutrients and antioxidant nutrients (vitamins A, E, C, selenium, zinc and copper) intake. Timepoint: Beginning and end of the trial. Method of measurement: Food record (gavage) - Nutritionist 4 software.;Intercellular adhesion molecule-1 (ICAM-1). Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Vascular cell adhesion molecule 1 (VCAM-1). Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Pro-oxidant-Antioxidant Balance (PAB). Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;Total antioxidant capacity (TAC). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method.;Malondialdehyde (MDA). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method.;Nitric oxide (NO). Timepoint: Beginning and end of the trial. Method of measurement: ELISA.;?Arylesterase (ARE) activity. Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrangiz Ebrahimi Mamagani

Tabriz University of Medical Sciences

ebrahimimamagani@tbzmed.ac.ir+98 41 3335 7580

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026